| CTRI Number |
CTRI/2026/01/100214 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
26/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Preventive |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to see whether applying Himawan Agad on the skin can help prevent nerve problems like numbness, tingling, and pain caused by Paclitaxel chemotherapy. |
|
Scientific Title of Study
|
Open Labelled Passive Controlled Clinical Evaluation of External Application of Himawan Agad as Prophylaxis in Paclitaxel Chemotherapy-Induced Peripheral Neuropathy (PIPN) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poorva Padmanabha Gogate |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital |
| Address |
Visha Chikitsa OPD
Department of Agadtantra
Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital Dhankawadi Pune
Pune MAHARASHTRA 411043 India |
| Phone |
8275764426 |
| Fax |
|
| Email |
poorvagogate0401@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prasad Namewar |
| Designation |
Professor, Head of Department |
| Affiliation |
Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital |
| Address |
Visha Chikitsa OPD
Department of Agadtantra
Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital Dhankawadi Pune
Pune MAHARASHTRA 411043 India |
| Phone |
9226269869 |
| Fax |
|
| Email |
prasad.namewar@bharatividyapeeth.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Prasad Namewar |
| Designation |
Professor, Head of Department |
| Affiliation |
Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital |
| Address |
Department of Agad tantra Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital Dhankawadi Pune
MAHARASHTRA 411043 India |
| Phone |
9226269869 |
| Fax |
|
| Email |
prasad.namewar@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Poorva Gogate |
| Address |
Department of Agad tantra Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital Dhankawadi Pune Maharashtra India 411043 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Poorva Padmanabha Gogate |
Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital |
Bharati Vidyapeeth Deemed to be University Visha Chikitsa OPD no 14 Katraj Dhankawadi Pune 411043 Pune MAHARASHTRA |
8275764426
poorvagogate0401@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BHARATI VIDYAPEETH (DEEMED TO BE UNIVERSITY) PUNE COLLEGE OF AYURVED PUNE SATARA ROAD PUNE411043 INSTITUTIONAL ETHICAL COMMITTEE [BV(DU)COA-IEC] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G620||Drug-induced polyneuropathy. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | viShopakramaH, विषोपक्रमः | (Procedure Reference: Y T Acharya, Procedure details: Positioning
The patient should sit or lie in a comfortable position exposing Palms and soles
Application
Apply a uniform layer (about 3 mm thick) of the prepared lepa over the palms
and soles
Cover the area with sterile gauze if needed to keep the paste intact and prevent
dripping
Avoid massage or rubbing
Contact Duration
Leave the lepa in place till it dries
Removal
Gently wipe off the lepa with a soft cotton cloth soaked in lukewarm water
Dry the area with a clean towel
Frequency of Application
Twice daily) (1) Medicine Name: Himawan Agad, Reference: Himawan Agad has been mentioned in Ashtanga Hriday Uttarsthana 36th adhyay, (Sarpavisha Pratishedha Adhyay). , Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Duration: 12 Weeks | | 2 | Comparator Arm (Non Ayurveda) | | - | NIL | NIL |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having Paclitaxel as their main chemotherapy drug
Patients planned for 12 weeks of paclitaxel chemo cycle
Age 18 to 70 years |
|
| ExclusionCriteria |
| Details |
Patients having Diabetic Neuropathy
Patients having Peripheral Neuropathy but with acute systemic adverse effects |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significantly reduce incidence and severity of PIPN |
Day0 Day14 Day28 Day35 Day56 Day70 Day84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Provide symptomatic relief from burning tingling and numbness in case of
development of PIPN
Improve nerve conduction and restore neurological functions |
Day0 Day14 Day28 Day35 Day56 Day70 Day84 |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
06/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Brief SummaryCancer is commonly treated with chemotherapy, but these
medicines often cause side effects that reduce a patient’s comfort and quality
of life. Paclitaxel, a widely used chemotherapy drug, is very effective against
cancers like breast, ovarian, and lung cancer, but it frequently causes
peripheral neuropathy a condition marked by tingling, burning, pain, numbness,
and loss of sensation in the hands and feet. These symptoms may become severe
or long-lasting, forcing doctors to reduce or stop chemotherapy. Himawan Agad,
a classical Ayurvedic formulation described in Ashtanga Hridaya, is
traditionally indicated for conditions involving burning, pain, inflammation,
and Vata-Pitta dominance. When used externally as Himawan Agad Lepa, mixed with
honey, it contains herbs known for pain relief, burn-relieving,
anti-inflammatory, neuroprotective, and tissue-healing actions. This study is
designed as an open-label passive-controlled clinical evaluation to assess the
preventive role of Himawan Agad Lepa in patients receiving Paclitaxel
chemotherapy. By applying the formulation externally, especially over
vulnerable areas like the lower limbs, the therapy aims to reduce the onset and
severity of neuropathic symptoms. The study seeks to establish a safe,
cost-effective, and integrative Ayurvedic approach for preventing
chemotherapy-induced peripheral neuropathy and improving patient comfort and
treatment continuity. |